BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 15936962 · Received December 7, 2022

    Report

    Report Number
    2029214-2022-02078
    Event Type
    Injury
    Date Received
    December 7, 2022
    Date of Event
    May 3, 2021
    Report Date
    December 7, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THOMAS LAURIN, OTTAVIA BORGHESE, JULIEN BRANCHEREAU, GEORGES KARAM, LAURENT BRISARD, TOM LE CORVEC, PHILIPPE CHAILLOU, HUBERT DESAL, ROMAIN BOURCIER, BLANDINE MAUREL; ANNALS OF VASCULAR SURGERY; 2022; 79:17-24; SINGLE CENTRE EXPERIENCE IN OPEN AND ENDOVASCULAR TREATMENT OF RENAL ARTERY ANEURYSMS; DOI.ORG/10.1016/J.AVSG.2021.07.024. MEDTRONIC RECEIVED INFORMATION THAT PATIENTS TREATED WITH A CONCERTO COIL HAD COMPLICATIONS. A TOTAL OF 27 PATIENTS (17 WOMEN, MEAN AGE 58) WERE INCLUDED. MEAN ANEURYSM WAS SIZE WAS 18.8 MM. MOST DIAGNOSIS WERE ACCIDENTAL. IT WAS A RETROSPECTIVE OBSERVATIONAL COHORT STUDY. ALL CONSECUTIVE PATIENTS PRESENTING WITH RENAL ARTERY ANEURYSM (RAA) OVER THE MAIN RENAL ARTERY OR ITS BRANCHES, TREATED BY EITHER OPEN OR ENDOVASCULAR SURGERY BETWEEN JANUARY 2005 TO MAY 2020 AT A SINGLE INSTITUTION WERE RETROSPECTIVELY INCLUDED. 13 PATIENT UNDERWENT ENDOVASCULAR PROCEDURES. FOR THE ENDOVASCULAR PROCEDURES A HUMERAL OR FEMORAL APPROACH WAS DONE. THE TARGETED RENAL ARTERY WAS CATHETERIZED BY A GUIDING CATHETER AND AN ANGIOGRAM WAS DONE. IF LESION PRESENTED WITH A TIGHT NECK, THE ANEURYSM WAS CATHETERIZED BY A MICRO-CATHETER AND CONCERTO EMBOLIZATION WAS PERFORMED. CONVERSELY WHEN A LARGER NECK WAS ENCOUNTERED, FIRSTLY THE EFFERENT BRANCHES OF THE RRA WERE PROTECTED BY AN INFLATED BALLOON  THEN THE ANEURYSM WAS EMBOLIZED BY CONCERTO. COMPLICATIONS: IN THE ENDOVASCULAR GROUP, THE 3-MONTHS POSTOPERATIVE MAGNETIC RESONANCE ANGIOGRAPHY (MRA) DETECTED ONE ENDOLEAK WITHOUT SAC ENLARGEMENT TREATED CONSERVATIVELY. THE GFR (GLOMERULAR FILTRATION RATE) WAS WITHIN NORMAL RANGE EXCEPT FOR 1 PATIENT FROM THE ENDOVASCULAR GROUP BUT NO PATIENT REQUIRED DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447692 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other